Peroxitech
A Revolutionary Answer to Acute Lung Injury Treatment

In an era where healthcare is being transformed by groundbreaking scientific research, Peroxitech, an emerging biotech company, is leading the way with a revolutionary solution for acute lung injury (ALI) – a condition that currently has no approved treatment.

In the U.S. alone, before COVID-19, approximately 190,000 patients suffered from ALI annually, which has a staggering 40 percent mortality rate. Those afflicted require mechanical ventilation for an average of 20 days, leading to costs upwards of $250,000 per patient. The devastating impact of ALI was particularly heightened during the COVID-19 pandemic, becoming the principal cause of death among patients.

Peroxitech’s innovative treatment called PIP-2, is poised to potentially transform this landscape as it approaches clinical trials.

In pre-clinical trials, PIP-2, demonstrated breakthrough data, showing lung protection, rescue, and improved mortality in several models of severe ALI

A Game-Changer in ALI Treatment

Dr. Aron Fisher, Emeritus Professor of Physiology and Director of the Institute for Environmental Medicine and Dr. Sheldon Feinstein, a former Senior Research Investigator in the Institute of Environmental Medicine, both at the University of Pennsylvania, discovered a new pathway with the potential to revolutionize ALI treatment. Peroxitech was formed to develop and commercialize PIP-2, a new chemical entity (NCE) targeting this novel pathway with support from the Penn Center for Innovation Ventures, Early on, Peroxitech made the strategic decision to study and establish compelling proof of concept data using PIP-2 in several ALI injury models to de-risk its core clinical development program. The effectiveness of the novel compound was highlighted during two separate animal mortality studies, both of which demonstrated an astounding 70 percent survival rate with PIP-2. Given that 100 percent of the animals would succumb to ALI in the placebo arm, this was a significant accomplishment, especially for an early-stage company.

These results have earned the attention of a number of parties, including Perceptive Xontogeny Venture (PXV) Fund, through which Peroxitech secured a Series A investment of $25 million in June 2022, to complete preclinical development and move PIP-2 into clinical trials.

Decoding the ALI Treatment Pathway

PIP-2 is a nine-amino acid peptide compound that is derived from human lung surfactant. It distinguishes itself as a Goldilocks-type compound, in that it is small enough (in terms of molecular structure and size) for significant uptake by the body and yet not too small that it gives rise to complications often associated with unintended side-effects.

The unique aspect of PIP-2 lies in its ability to disrupt the reactive oxygen species (ROS) activation process. While ROS is an important aspect of our normal immune response, events like severe injuries, infections, or trauma can lead to its excessive production. This can cause cell and tissue damage that in turn, leads to lung inflammation through the initiation of a cytokine storm. Previous attempts to curb ROS overproduction in ALI have been unscuccessful.

PIP-2’s mode of action obstructs the cascade reaction in the initial phase of ROS activation, effectively preventing the body from inadvertently harming itself. The compound’s animal efficacy data is promising and has held steady over the course of several models and injury scenarios. When administered well after the onset of ALI, PIP-2 restored normal lung function. In two separate ALI mortality outcome studies, PIP-2 demonstrated a 70 percent survival rate after five days versus zero percent for the placebo arm.

Developing compelling efficacy data in realistic, worst-case scenarios has been a key aspect in Peroxitech’s DNA and success

PIP-2’s capacity can potentially revolutionize critical care scenarios for ALI, offering the prospect of breakthrough recoveries from life-threatening conditions. This is an undeniably exhilarating prospect, underlining Peroxitech’s commitment to breaking new ground in medical science and offering innovative solutions to pressing healthcare challenges.

“Developing compelling efficacy data in realistic, worst case scenarios has been a key aspect in Peroxitech’s DNA and success,” says Han.

Navigating the Path to Human Trials

To pave the way for a seamless progression into human trials, Peroxitech is designing studies that can directly link back to its research in animal models, reducing the risk of failure during Phase 2 and Phase 3 trials. The steadfast efficacy of the compound and the fact that the targeted pathway is conserved across animals and humans, bolsters confidence that the findings in animal studies will translate well to human applications.

Peroxitech is currently advancing through IND enabling safety studies and is also developing an biomarker using immune cells to further de-risk clinical trials. It is actively engageed in collaborative opportunities with esteemed institutions, CDMOs, and CROs to tap into specialized expertise for optimizing development processes while establishing long-term relationships with partners crucial to progress.

One such collaboration is with the National Institutes of Health, which has long worked to identify and develop cutting edge science for ALI. Peroxitech has been awarded several NIH grants supporting developments of PIP-2 for ALI.

Peroxitech also leverages a diverse group of experts, including investors with clinical experience, who provide an objective perspective, guarding against groupthink—a common pitfall in small organizations. Its strategic partnership with PXV offers access to a network of experts, in addition to providing financial support and strategic guidance.

Another collaboration is with Dr. Shampa Chatterjee, a world-class researcher from the University of Pennsylvania, Perelman School of Medicine. Peroxitech is working with Dr. Chatterjee to explore additional indications and support discoveries that can significantly increase value and de-risk the ongoing clinical development program. Dr. Chatterjee has also employed her pre-clinical discovery platform to secure NIH funding for novel uses for PIP-2. This strategic approach allows Peroxitech to achieve scientific, operational and clinical development expertise and support akin to a much larger pharmaceutical company while conserving resources and maximizing flexibility.

Going Beyond the IND Milestone

Peroxitech is currently in the midst of conducting IND toxicology studies that are anticipated to finish within the next year. Early indications point toward a favorable profile, marked by strong tolerability and minimal toxicity. The immediate focus for the company is advancing PIP-2 through key developmental checkpoints. With the IND submission a pivotal milestone on the horizon, the timeline for the commencement of its Phase 1 study is poised for late next year, with further progression into Phase 2 targeted for the outset of 2025.

Beyond its commitment to clinical development, Peroxitech’s drive for medical innovation has led to a deeper exploration of PIP-2’s mechanism of action for additional oxidative injury and inflammatory diseases. Peroxitech envisions the utilization of PIP 2 in addressing several conditions characterized by the absence of viable treatments, each harboring the potential to become a blockbuster indication in its own right. PIP-2, a small peptide with demonstrable low toxicity levels, underpins the promise of its applicability across a broad spectrum of medical conditions.

Simply put, PIP-2 appears to be a groundbreaking compound with immense potential to turn the tide in the healthcare sector. Peroxitech’s pioneering work with this novel compound has yielded a solution that can be a beacon of hope for mitigating the detrimental effects of ALI.